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510(k) Data Aggregation
(266 days)
NDW
Diazyme Colorimetric Lithium Assay kit is for quantitative in vitro determination of lithium in human serum or EDTA plasma. Measurements of lithium are carried out to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.
Not Found
This document is an FDA 510(k) clearance letter for the Diazyme Colorimetric Lithium Assay. It formally grants permission to market the device based on a determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information regarding acceptance criteria and performance data.
The letter primarily covers:
- Confirmation of 510(k) review and clearance.
- The trade/device name, regulation number/name, regulatory class, and product code.
- General controls and additional regulations applicable to the device (e.g., Quality System regulation, UDI rule, MDR).
- Contact information for FDA resources.
- The "Indications for Use" statement for the device.
To answer your specific questions, one would typically need access to the 510(k) submission document itself, specifically the performance data sections. The provided FDA letter is the clearance notice, not the supporting technical file.
Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. The letter confirms that a review was done and clearance granted, implying that the device did meet acceptance criteria demonstrated in the submission, but it does not detail those criteria or the study results.
To answer your questions, I would need a different document, such as the actual 510(k) application's test report or a summary of safety and effectiveness data (SSE) that outlines the performance studies.
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(101 days)
NDW
The LITH method is an in vitro diagnostic test for the quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System. Measurements of lithium are used to assure that the proper drug dosage is administered in the treatment of patients with mental disturbances, such as manic-depressive illness (bipolar disorder).
The Drug 4 CAL is an in vitro diagnostic product for the calibration of the LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System.
The LITH method employs a lithium-specific chromoionophore that forms a complex with the Li+ ion in an alkaline solution. The concentration of lithium in the sample is proportional to the increase in absorbance, which is due to the formation of the dye-lithium complex. The reaction is measured using a Bichromatic (510 and 700 mm) endpoint technique.
The Drug 4 Calibrator is a five (5) level, liquid calibrator. It is packaged as a kit of ten vials per level (A, B, C, D and E), 2.5 mL per vial. The product matrix is liquid human serum and contains digoxin and lithium. This product is sold separately from the Flex® reagent cartridge.
Here's a breakdown of the acceptance criteria and study information for the Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator, based on the provided text:
Overview:
The submission focuses on demonstrating "substantial equivalence" to predicate devices. This means the new devices (Dimension Vista® Lithium Flex® Reagent Cartridge and Dimension Vista® Drug 4 Calibrator) perform similarly enough to existing, legally marketed devices (Dimension® Lithium Flex® Reagent Cartridge K011033 and Dimension® Drug Calibrator K011035) that they don't raise new questions of safety or effectiveness. The primary study type is comparative testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly met if the new device performs comparably to the predicate device, as demonstrated through comparative testing. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance."
Here’s a table summarizing the features compared, which serve as the basis for demonstrating substantial equivalence:
Dimension Vista® Lithium (LITH) Flex® Reagent Cartridge vs. Predicate (K011033)
| Feature | Acceptance Criteria (Predicate: Dimension® Lithium (LI) K011033) | Reported Device Performance (Dimension Vista® Lithium (LITH) K4150) |
|---|---|---|
| Intended Use | Quantitative measurement of lithium in human serum and plasma on Dimension® systems for drug dosage assurance in mental disturbances. | Quantitative measurement of lithium in human serum and plasma on the Dimension Vista® System for drug dosage assurance in mental disturbances. (Identical) |
| Sample Type | Serum and Sodium Heparin Plasma | Serum and Sodium Heparin Plasma |
| Measuring Range | 0.20 - 5.00 mmol/L | 0.20 - 3.00 mmol/L |
| Sample Size | 10 µL | 2 µL |
| Measurement | Bichromatic endpoint (540 and 700 nm) | Bichromatic endpoint (510 and 700 nm) |
Dimension Vista® Drug 4 Calibrator vs. Predicate (K011035)
| Feature | Acceptance Criteria (Predicate: Dimension® Drug Calibrator K011035) | Reported Device Performance (Dimension Vista® DRUG 4 CAL KC460A) |
|---|---|---|
| Intended Use | Calibration of DIG, LI, PHNO, PTN, and THEO methods on Dimension Vista® System. | Calibration of LOCI Digoxin (DIGXN) and Lithium (LITH) methods on the Dimension Vista® System. |
| Matrix | Human serum based | Human serum based |
| Preparation | Liquid: Provided ready to use. | Liquid: Provided ready to use. |
| Target Concentrations | Level 1: ≤ 0.20 mmol/L | |
| Level 2: 0.80 - 1.00 mmol/L | ||
| Level 3: 1.71 - 1.89 mmol/L | ||
| Level 4: 3.42 - 3.78 mmol/L | ||
| Level 5: 5.22 - 5.78 mmol/L | Level 1: ≤ 0.20 mmol/L | |
| Level 2: 0.77 - 1.15 mmol/L | ||
| Level 3: 1.67 - 2.00 mmol/L | ||
| Level 4: 3.35 - 3.85 mmol/L | ||
| Level 5: 5.12 - 5.89 mmol/L | ||
| Storage | Store at 2 to 8 °C. | Store at 2 - 8 °C. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance." However, the exact sample sizes for the test set (e.g., number of patient samples, controls) are not specified within the provided text.
The data provenance is also not explicitly stated (e.g., country of origin, retrospective/prospective). As an in vitro diagnostic device, it's highly likely that samples would be human serum and plasma, but the source specifics are missing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable and not provided in the context of this device. This is a quantitative chemical assay, not an imaging device or diagnostic interpretation requiring expert human adjudication. The "ground truth" for calibrators and reagent cartridges like these is typically established through analytical methods, reference materials, and specified concentrations, not expert consensus.
4. Adjudication Method for the Test Set
Not applicable and not provided. As explained in point 3, this is a quantitative chemical assay, not a diagnostic interpretation that would involve adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating a diagnostic aid that assists human readers (e.g., AI in radiology). The devices in question are reagents and calibrators for a laboratory instrument, not tools for human interpretation.
6. If a Standalone Performance Study was Done
Yes, in essence, standalone performance was assessed as part of the "comparative testing" mentioned. For an in vitro diagnostic device, demonstrating performance against a predicate device (rather than a human reader) is the standard. The device's performance properties (e.g., precision, measuring range, analytical specificity) would be evaluated when operating on its own as designed, and then these results would be compared to the predicate. The document states "Comparative testing described in the submission report demonstrates substantial equivalent performance," indicating the new device's performance was measured.
7. The Type of Ground Truth Used
The ground truth for these types of devices is based on analytical validation and reference methods.
For the Lithium Flex® Reagent Cartridge: The "ground truth" for lithium concentration in samples would be established by reference methods or validated comparative methods, against which the device's quantitative measurements are compared to assess accuracy, precision, and linearity.
For the Drug 4 Calibrator: The "ground truth" for the calibrator's target concentrations (Levels 1-5) is established by precise formulation and measurement against recognized standards. The matrix itself (human serum) is a specified component.
8. The Sample Size for the Training Set
Not applicable and not provided. These are chemical reagents and calibrators for an IVD assay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The development and optimization of such reagents involve experimental design, formulation studies, and analytical verification, rather than machine learning training.
9. How the Ground Truth for the Training Set was Established
Not applicable and not provided. As explained in point 8, there is no "training set" in the context of these devices.
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(465 days)
NDW
In vitro test for the quantitative determination of lithium in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of lithium are used as an aid in the management of patients taking lithium for the treatment of mental disturbances such as manic-depressive illness (bipolar disorder).
The cassette cobas c501 Lithium contains an in vitro diagnostic reagent system intended for use on Roche/Hitachi cobas c systems for the quantitative determination of lithium in human serum and plasma. The test principle is colorimetric.
The provided text describes a 510(k) submission for the cobas c501 Lithium test system. It outlines the device's intended use, its similarities and differences to a predicate device, and various performance characteristics. However, the document does not contain information typically associated with acceptance criteria or studies proving device performance for AI/ML-driven diagnostics, as none of the requested fields directly apply to this type of medical device.
The device described is an in vitro diagnostic reagent system for the quantitative determination of lithium in human serum and plasma, using a colorimetric test principle. This is a chemical assay, not an AI/ML-driven diagnostic device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, AUC, and human reader improvement) are not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (COBAS INTEGRA ISE Direct) by comparing analytical performance characteristics relevant to chemical assays.
Given the nature of the device, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance in relation to AI/ML metrics. It provides analytical performance characteristics like precision, linearity, and interference.
- Sample size used for the test set and data provenance: While method comparison data is mentioned (e.g., Passing Bablok regression), the specific sample size and data provenance for demonstrating equivalence are not detailed in the provided text.
- Number of experts and qualifications for ground truth: Not applicable for a chemical assay.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data): Not applicable in the AI/ML sense. The ground truth for a chemical assay would be reference methods (e.g., Atomic Absorption Spectroscopy as mentioned for traceability).
- Sample size for the training set: Not applicable as it's not an AI/ML model.
- How ground truth for the training set was established: Not applicable.
However, I can extract the analytical performance characteristics that are presented, which serve as evidence of the device's performance for this type of IVD.
Analytical Performance Characteristics of the cobas c501 Lithium (Modified Device)
While the typical "acceptance criteria" for AI/ML are not present, the following analytical performance characteristics are reported for the cobas c501 Lithium system, indicating its performance compared to the predicate and overall suitability:
| Performance Characteristic | Acceptance Criteria (Implicit via predicate comparison or industry standards for IVDs) | Reported Device Performance (cobas c501 Lithium) |
|---|---|---|
| Precision | Demonstrated precision comparable to or better than predicate. | Within run CV: |
| 1.7% @ 0.77 mmol/L | ||
| 1.0% @ 2.38 mmol/L | ||
| 1.9% @ 0.46 mmol/L | ||
| 1.2% @ 1.40 mmol/L | ||
| Total: | ||
| 2.2% @ 0.79 mmol/L | ||
| 1.3% @ 2.42 mmol/L | ||
| 2.3% @ 0.61 mmol/L | ||
| 1.6% @ 1.62 mmol/L | ||
| Endogenous Interferences | No significant interference at specified levels for common interferents. | Hemolysis: No significant interference up to H index of 1000 |
| Icterus: I index of 37 for conjugated and 43 for unconjugated bilirubin | ||
| Lipemia: L index of 2000 | ||
| Exogenous Interferences | No significant interference from common exogenous substances. | NH4Cl: 19.8 umol/L |
| NaCl : 140 mmol/L | ||
| KCl : 4 mmol/ L | ||
| CaCl2: 2.4 mmol/L | ||
| MgCl2: 0.9 mmol/L | ||
| FeCl3: 1.04 mg/L | ||
| Cu (NO3)2: 1.15 mmol/L | ||
| ZnCl2: 1.07 mmol | ||
| (none of these are in the physiological key interference range) | ||
| In very rare cases gammopathy | ||
| Limit of Detection (LOD) | Clinically meaningful detection limit. | 0.05 mmol/L |
| Limit of Blank (LOB) | Defined blank. | 0.03 mmol/L |
| Measuring Range | Clinically relevant measurable range. | 0.05-3.00 mmol/L |
| Extended measuring range: 0.05-6.00 mmol/L |
Study Information (as it pertains to this IVD):
The document mentions "Performance evaluation" was done for several characteristics, but does not provide details on specific study designs, sample sizes, or data provenance beyond what is implicit in standard IVD validation.
- Sample size for test set and data provenance: Not explicitly stated for specific performance studies. The method comparison data includes parameters like Passing Bablok regression (y = 1.037x + 0.004, $\tau$ = 0.940) and Linear regression (y = 1.044x -0.000, r = 0.995) which imply a comparison study with an unspecified number of samples. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.
- Number of experts and qualifications for ground truth: Not applicable for a chemical assay. The ground truth for this device would be established by reference methods.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance: The performance characteristics listed (precision, interference, limits) represent the standalone analytical performance of the device. This is the equivalent of "algorithm only" performance for a chemical assay.
- Type of ground truth: For analytical performance testing, the ground truth would be established by validated reference methods or materials (e.g., Atomic Absorption Spectroscopy for traceability, or gravimetrically prepared reference materials for calibrators).
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
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(300 days)
NDW
Lithium is intended for in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 Clinical Chemistry Analyzers. Measurements are used as an aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
Theophylline is intended for quantitative in vitro diagnostic determination of the theophylline concentration in human serum using T60 Clinical Chemistry Analyzers. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy.
The ISE Calibrators 1 and 2 & 3 are intended for calibration of ion selective electrodes for quantitative measurements of potassium, sodium and chloride in human serum or plasma and lithium in human serum. For the in vitro diagnostic use on the T60 analyzer.
TDM Calibration set B is intended for in vitro diagnostic use as a calibrator in the quantitative measurement of the kit code 981649 Theophylline assay on T60 Analyzer.
Not Found
The provided document describes the acceptance criteria and study results for two devices: the Lithium Micro Volume Electrode and Theophylline. Both are in vitro diagnostic devices for quantitative determination in human serum on T60 Clinical Chemistry Analyzers.
Here's a breakdown of the requested information for each device:
Lithium Micro Volume Electrode
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device with a predicate device (Infinity™ Lithium Reagent for Olympus®). Performance metrics are presented for both devices, allowing for implicit comparison rather than explicit acceptance criteria.
| Attribute | Acceptance Criteria (New Device) - Implied from Predicate | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of lithium concentration in human serum. | For in vitro diagnostic use in the quantitative determination of the lithium concentration in human serum on T60 analyzer. |
| Indication for Use | Aid in management of individuals taking lithium for mental disturbances. | Aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). |
| Assay Protocol | (Predicate: Spectrophotometric) | Potentiometric |
| Traceability/Standardization | (Predicate: Not specified) | NIST SRM 924 |
| Sample Type | Serum | Serum |
| Measuring Range | Similar to predicate (0.04 - 3.00 mmol/l) | 0.2 - 4.0 mmol/l |
| Precision (Within run) | Level 0.57 mmol/l: CV(%) = 0.9; Level 1.83 mmol/l: CV(%) = 0.7 (predicate) | Level 0.95 mmol/l: SD = 0.008, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.017, CV(%) = 0.9 |
| Precision (Between run) | (No explicit predicate for between-run provided) | Level 0.95 mmol/l: SD = 0.009, CV(%) = 0.9; Level 1.86 mmol/l: SD = 0.009, CV(%) = 0.5 |
| Precision (Total) | Level 0.57 mmol/l: CV(%) = 1.9; Level 1.83 mmol/l: CV(%) = 1.3 (predicate) | Level 0.95 mmol/l: SD = 0.020, CV(%) = 2.1; Level 1.86 mmol/l: SD = 0.039, CV(%) = 2.1 |
| Method Comparison (Correlation) | r = 0.9956 (predicate) | r = 0.999 |
| Method Comparison (Equation) | y = 1.01x - 0.007 (predicate) | y = 0.98x - 0.01 |
| Method Comparison (Range) | 0.11 - 1.73 mmol/l (predicate) | 0.25 - 4.09 mmol/l |
| Limitations (Bilirubin) | No significant interference up to 45 mg/dl (predicate) | No interference found up to 41 mg/dl (700 µmol/l) of conjugated Bilirubin |
| Limitations (Lipemia) | No significant interference up to 22.6 mmol/l (2000 mg/dl) (predicate) | No interference found up to 1000 mg/dl (10 g/l) of Intralipid® |
| Limitations (Hemolysate/Hemoglobin) | No interference up to 2 g/l (predicate) | No interference found up to 1000 mg/dl (10 g/l) of hemoglobin |
2. Sample size used for the test set and the data provenance
- Sample Size: N = 117 samples were used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's a 510(k) submission, it's typically clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a standalone diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (Lithium Micro Volume Electrode) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established by a predicate device (NOVA ISE), which is a legally marketed device for lithium measurement. The method comparison data shows correlation against this established method.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Theophylline
1. Table of Acceptance Criteria and Reported Device Performance
The document compares the new device with a predicate device (The CEDIA® Theophylline II Assay). Performance metrics are presented for both devices for implicit comparison rather than explicit acceptance criteria.
| Attribute | Acceptance Criteria (New Device) - Implied from Predicate | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Quantitative determination of theophylline concentration in human serum for diagnosis and treatment of overdose and therapy monitoring. | For in vitro diagnostic use in the quantitative determination of the theophylline concentration in human serum on T60 analyzer. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to help ensure proper therapy. |
| Indication for Use | Same as intended use. | Same as intended use. |
| Assay Protocol | Homogeneous enzyme immunoassay using recombinant DNA technology. | Assay uses recombinant DNA technology (US Patent no. 4708929) to produce a unique homogeneous enzyme immunoassay system. |
| Traceability/Standardization | (Predicate: Not specified) | The calibration values are traceable to USP reference materials prepared gravimetrically to drug-free human serum. |
| Sample Type | Serum | Serum |
| Measuring Range | Between 0.8 µg/ml and approx. 40 µg/ml (predicate) | From 1.4 µg/ml or 7.8 µmol/l to 40 µg/ml or 222 µmol/l. |
| Precision (Within run) | Level 5.1 µg/ml: CV(%) = 3.3; Level 15.1 µg/ml: CV(%) = 1.9; Level 29.3 µg/ml: CV(%) = 1.3 (predicate) | Level 4.4 µg/ml: SD = 0.17, CV(%) = 3.9; Level 13.8 µg/ml: SD = 0.21, CV(%) = 1.5; Level 28.1 µg/ml: SD = 0.21, CV(%) = 0.8 |
| Precision (Total) | Level 5.1 µg/ml: CV(%) = 5.1; Level 15.1 µg/ml: CV(%) = 2.4; Level 29.3 µg/ml: CV(%) = 2.0 (predicate) | Level 4.4 µg/ml: SD = 0.35, CV(%) = 8.0; Level 13.8 µg/ml: SD = 0.59, CV(%) = 4.3; Level 28.1 µg/ml: SD = 0.87, CV(%) = 3.1 |
| Method Comparison (Correlation) | r = 0.997 (predicate) | r = 0.998 |
| Method Comparison (Equation) | y = 1.01x - 0.41 (predicate) | y = 0.989x + 0.05 |
| Method Comparison (Range) | 0.9 - 37.4 µg/ml (predicate) | 1.1 - 37.7 µg/ml |
| Limitations (Bilirubin) | No significant interference up to 66 mg/dl (predicate) | No interference found up to 58 mg/dl (1000 µmol/l) |
| Limitations (Hemoglobin) | No significant interference up to 1000 mg/dl (predicate) | No interference found up to 1000 mg/dl (10 g/l) |
| Limitations (Lipemia) | No significant interference up to L index of 1000 (approx. 2000 mg/dl triglycerides) (predicate) | No interference found up to 1000 mg/dl (10 g/l) of Intralipid® |
| Limitations (Uremic patients) | Should not be used due to cross-reactivity with 1,3-Dimethyluric Acid (predicate) | Due to cross-reactivity with 1,3-Dimethyluric Acid, the Theophylline assay should not be used to quantitate samples from uremic patients. |
2. Sample size used for the test set and the data provenance
- Sample Size: N = 133 samples were used for the method comparison study.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, as a 510(k) submission, it typically involves clinical samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device performs quantitative chemical analysis, where instrument readings and reference methods (predicate device for comparison) establish the ground truth, not human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for quantitative chemical analysis. Ground truth is established by the reference method (predicate device in this case), not by expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a standalone diagnostic device for chemical analysis, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device (Theophylline) is a standalone diagnostic tool. Its performance is measured directly against a predicate device and established analytical parameters like precision.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the test set was established by a commercially available fluorescence polarization immunoassay (the predicate device). The method comparison data shows correlation against this established method.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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(118 days)
NDW
A lithium test system is a device intended to measure lithium levels in serum or plasma. Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder). For use on Architect and Aeroset analyzers.
The Multigent Lithium test is a spectrophotometric method, which can be readily adapted to automated clinical chemistry analyzers. Lithium present in the sample reacts with a substituted porphyrin compound at an alkaline pH, resulting in a change of absorbance, which is directly proportional to the concentration of lithium in the sample.
Here's a breakdown of the acceptance criteria and study information for the Multigent Lithium device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Predicate Device: Infinity Lithium Liquid Stable Reagent assay on Hitachi 911 Analyzer) | Achieved Performance (Multigent Lithium) |
|---|---|---|
| Correlation | Correlation coefficient: Not explicitly stated for acceptance, but implied to be high for equivalence. | AEROSET System: 0.999 |
| ARCHITECT c8000 System: 0.999 | ||
| Slope | Slope: Not explicitly stated for acceptance, but implied to be near 1 for equivalence. | AEROSET System: 1.013 |
| ARCHITECT c8000 System: 0.991 | ||
| Y-intercept | Y-intercept: Not explicitly stated for acceptance, but implied to be near 0 for equivalence. | AEROSET System: -0.025 mmol/L |
| ARCHITECT c8000 System: -0.004 mmol/L | ||
| Precision (%CV) | %CV: Not explicitly stated for acceptance, but implied to be functionally acceptable for clinical use. | AEROSET System: Level 1: 4.76%, Level 2: 3.67%, Level 3: 2.96% |
| ARCHITECT c8000 System: Level 1: 2.53%, Level 2: 1.88%, Level 3: 2.02% | ||
| Linearity (Upper Limit) | Linearity: Not explicitly stated for acceptance, but implied to cover the clinical range. | Up to 3.51 mmol/L |
| Limit of Quantitation (Sensitivity) | Sensitivity: Not explicitly stated for acceptance, but implied to be clinically relevant. | 0.10 mmol/L |
Note: The acceptance criteria are implicitly defined by the claim of "similar Performance Characteristics" and "substantially equivalent" to the predicate device. Specific numerical thresholds for acceptance are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the comparative performance studies. It mentions "comparative performance studies were conducted," but details on the number of samples are absent.
- Data Provenance: Not specified. It's unclear if the data was collected retrospectively or prospectively, or the country of origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is a diagnostic reagent for measuring lithium levels, which are typically determined by laboratory analysis and not by expert human interpretation of images or other subjective data. The "ground truth" in this context would be the actual concentration of lithium in the samples, as determined by the predicate device (Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer) or a reference method.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this study involves objective chemical measurements, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for devices that involve human interpretation of diagnostic images (e.g., radiology AI), not for objective chemical assays like this lithium test.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this study is inherently a standalone performance evaluation of the Multigent Lithium assay. It compares the analytical performance of the new assay directly against a predicate device, without involving human interpretation as an outcome. The device itself performs the measurement.
7. The Type of Ground Truth Used
The ground truth for the device's performance comparison was the results obtained from the predicate device, the Infinity Lithium Liquid Stable Reagent assay on the Hitachi 911 Analyzer.
8. The Sample Size for the Training Set
Not applicable. For a diagnostic reagent intended for chemical measurement, there isn't typically a "training set" in the machine learning sense. The assay is developed based on chemical principles and extensively tested for analytical performance.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there isn't a traditional "training set" with ground truth in this context. The development process would involve optimizing the reagent's formulation and reaction conditions to accurately measure lithium, with performance validated against reference methods and established predicate devices.
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(121 days)
NDW
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in the treatment of bipolar disorder.
The Bayer ADVIA IMS Lithium (LITH) method is an in vitro diagnostic device intended to measure lithium in human serum and plasma. Such measurements are used as an aid in monitoring lithium levels during the treatment of bipolar disorder.
The Assayed Chemistry Control 1 and Control 2 are for in vitro diagnostic use to monitor the performance of chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
The Chemistry Calibrator is for in vitro diagnostic use in the calibration of chemistry assays on chemistry systems, including the ADVIA® IMS, ADVIA® Chemistry, and Technicon RA® and opeRA systems.
Not Found
Here's a breakdown of the acceptance criteria and study information for the Bayer ADVIA IMS Lithium method, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device and provides performance data rather than explicit pre-defined "acceptance criteria" in a go/no-go fashion. However, we can infer performance targets or expectations based on the predicate device's performance and the regression analysis.
| Performance Metric | Acceptance Criteria (Inferred/Predicate) | Reported Device Performance (ADVIA IMS) |
|---|---|---|
| Imprecision (Total CV%) | Comparable to or better than predicate device (ThermoTrace) | |
| - Level ~1.00 - 1.15 mmol/L | ThermoTrace: 3.9% | 2.3% |
| - Level ~2.06 - 2.49 mmol/L | ThermoTrace: 3.6% | 1.8% |
| Correlation (with CDC Flame) | Strong correlation (R close to 1, small Syx) | R = 0.997, Syx = 0.06 mmol/L |
| Correlation (with ThermoTrace) | Strong correlation (R close to 1, small Syx) | R = 0.997, Syx = 0.05 mmol/L |
| Interference (Bilirubin unconjugated) | Clinically insignificant effect | 6% change at 30 mg/dL Bilirubin |
| Interference (Bilirubin conjugated) | Clinically insignificant effect | -2% change at 30 mg/dL Bilirubin |
| Interference (Hemoglobin) | Clinically insignificant effect | -2% change at 1000 mg/dL Hemoglobin |
| Interference (Lipids/Triglycerides) | Clinically insignificant effect | -9% change at 500 mg/dL Lipids |
| Analytical Range | Adequate for clinical use (e.g., matching predicate) | 0.10 - 3.00 mmol/L |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Correlation Studies: 49 samples (N=49) for both the comparison with CDC Flame and ThermoTrace systems.
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It is a 510(k) submission, which typically involves internal validation testing by the manufacturer. Assuming typical practices, the samples were likely collected prospectively for the purpose of the study, and the origin is probably related to the manufacturer's testing facilities (e.g., within the US or a region where Bayer operates).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- None applicable. This is an in vitro diagnostic device for measuring a chemical analyte (Lithium). "Ground truth" for clinical decisions or image interpretation by experts is not relevant here. The ground truth for the comparison studies is established by reference methods or predicate devices (CDC Flame, ThermoTrace).
4. Adjudication Method for the Test Set:
- None applicable. As detailed in point 3, there are no "experts" in the sense of clinical decision-makers adjudicating results. The comparison methods act as the reference.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is not relevant for this type of in vitro diagnostic device, which directly measures a chemical concentration rather than assisting human readers in interpreting complex diagnostic information (like medical images).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes. The entire submission details the standalone performance of the ADVIA IMS Lithium method. The "device" is the algorithm/system for measuring lithium. There isn't a human-in-the-loop component in the measurement process itself, although a human interprets the numerical results for patient management. The data presented for imprecision, correlation, and interference are all standalone performance metrics.
7. The Type of Ground Truth Used:
- Reference Method/Predicate Device Measurements:
- For the correlation study with "Comparison System (X) CDC Flame," the ground truth for lithium concentration was established by the Centers for Disease Control (CDC) Flame Photometer, which is a recognized reference method.
- For the correlation study with "Comparison System (X) ThermoTrace," the ground truth was established by the predicate device, the ThermoTrace Lithium method.
- For imprecision and interference studies, the ground truth is often established by precise gravimetric or volumetric preparation of known concentrations, confirmed by a reference method.
8. The Sample Size for the Training Set:
- Not explicitly stated/not applicable in the same way as AI/ML. This device is a traditional immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the common sense for model development. The development process would involve method development, reagent formulation, and analytical validation rather than machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. As described above, this is a traditional in vitro diagnostic assay, not an AI/ML system requiring a training set with established ground truth labels for learning. The "ground truth" during development would be based on known chemical concentrations and performance against established analytical standards.
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